Manager CMC Regulatory Sciences - Pre-Approval
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Troy, New York
- Start date
- Jun 5, 2023
View more
- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
We are currently looking to fill a Manager CMC Regulatory Sciences. The manager is responsible for overseeing teams leading CMC regulatory submission work across multiple programs and/or submissions
In this role, a typical day might include the following:
- Managing and developing CMC Regulatory Sciences (CMC RS) staff/direct reports (including contributing to regulatory strategy discussions and project direction).
- Provide management support at cross-functional and team meetings related to program submission strategies (timelines, approach, deliverables), while developing excellent relationships with a variety of functional areas and cross functional teams, contract manufacturing organizations, as well as global regulatory partners.
- Oversees (in collaboration with writing teams) the completion of CMC RS regulatory submissions, manages workload and provides direction to CMC RS Specialists and/or other CMC RS staff.
- Helps prepare and/or reviews a variety of CMC regulatory submissions and supporting documents including dossier content (BLAs, MAAs, supplements), meeting requests and briefing books, ensuring that all submissions are complete, accurate, and meet relevant requirements.
- Assists with the timely and accurate assembly of responses to inquiries from regulatory agencies on the content of CMC documents
- Collaborates with project teams to support activities related to the finalization of CMC documents in accordance with established timelines, keeping all team members, including external partners when applicable, informed of progress and raising risks (and mitigation options) as necessary.
- When applicable, interacts with regulatory authorities from US and international health agencies in support of the CMC modules of regulatory submissions.
- Reviews and/or approves CMC submission content, ancillary CMC documents and reports for completeness and accuracy and for compliance with regulations.
- Contributes to the development and execution of CMC regulatory strategies for programs
- Identifies project issues and contributes to development of alternate strategies.
- Keeps management advised of decisions, overall strategy and project status.
- Have excellent written and verbal communication skills,
- Strong skills in planning, critical thinking and problem-solving,
- Are comfortable dealing with shifting priorities and changes in strategy,
- Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a level of attention to detail,
- Knowledge of drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).
To be considered for the Software Developer position, applicants should have:
BS/BA degree in Chemistry, Biology or related field, with relevant experience or equivalent combination of education and experience, preferably pharmaceutical or medical device, including some supervisory and/or leadership experience. Regulatory experience is a plus.
- Associate Manager: Requires 6+ years of proven experience
- Manager: Requires 7+ years of proven experience
- Senior Manager: Requires 8+ years of proven experience
- Level is determined based on qualifications relevant to the role.
Salary Range (annually)
$85,800.00 - $157,400.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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